SUCRALFATE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

SUCRALFATE (UNII: XX73205DH5) (SUCRALFATE - UNII:XX73205DH5)

제공처:

H.J. Harkins Company, Inc.

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Sucralfate tablets, USP are indicated in: - Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination. - Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. Sucralfate tablets are contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

SUCRALFATE- SUCRALFATE TABLET
H.J. HARKINS COMPANY, INC.
----------
1025-00,01,06
Sucralfate, USP is an α-D-glucopyranoside, β-D-fructofuranosyl-,
octakis(hydrogen sulfate), aluminum
complex.
R = SO3Al(OH)2
Tablets for oral administration contain 1 g of sucralfate, USP and the
following inactive ingredients:
corn starch, magnesium stearate, and microcrystalline cellulose.
Sucralfate is only minimally absorbed from the gastrointestinal tract.
The small amounts of the sulfated
disaccharide that are absorbed are excreted primarily in the urine.
Although the mechanism of sucralfate’s ability to accelerate healing
of duodenal ulcers remains to be
fully defined, it is known that it exerts its effect through a local,
rather than systemic, action. The
following observations also appear pertinent:
1.
Studies in human subjects and with animal models of ulcer disease have
shown that sucralfate forms an
ulcer-adherent complex with proteinaceous exudate at the ulcer site.
2.
In vitro, a sucralfate-albumin film provides a barrier to diffusion of
hydrogen ions.
3.
In human subjects, sucralfate given in doses recommended for ulcer
therapy inhibits pepsin activity in
gastric juice by 32%.
4.
In vitro, sucralfate adsorbs bile salts.
These observations suggest that sucralfate’s antiulcer activity is
the result of formation of an ulcer-
adherent complex that covers the ulcer site and protects it against
further attack by acid, pepsin, and bile
salts. There are approximately 14 to 16 mEq of acid-neutralizing
capacity per 1 g dose of sucralfate.
Sucralfate tablets, USP are indicated in:
Short-term treatment (up to 8 weeks) of active duodenal ulcer. While
healing with sucralfate may
occur during the first week or two, treatment should be continued for
4 to 8 weeks unless healing
has been demonstrated by x-ray or endoscopic examination.
Maintenance therapy for duodenal ulcer patients at reduced dosage
after healing of acute ulcers.
Sucralfate tablets are contraindicated in patients with known
hypersensitivity reactions to the acti